A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe
- Registration Number
- NCT01344863
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This randomized, open-label, parallel, 2-arm, multicenter study will compare the administration of Herceptin (trastuzumab) with a single-use injection device versus a handheld syringe in healthy male volunteers. The volunteers will receive a single dose of 600 mg Herceptin. The anticipated time of the study is 21 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 119
Inclusion Criteria
- Healthy male patients, 18 to 45 years of age, inclusive
- No history of hypersensitivity or allergic reactions following drug administration
- No history of clinically significant or clinically relevant cardiac condition
- No history of previous anticancer treatment
- Body mass index (BMI) between 18-32 kg/m2, inclusive
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Exclusion Criteria
- Positive test result for drugs of abuse
- Positive test result for hepatitis B, hepatitis C, or HIV 1 or 2
- Systolic blood pressure greater than 140 mmHG or less than 90 mmHG, or diastolic blood pressure greater than 90 mmHG or less than 50 mmHG
- Clinically significant abnormal laboratory values
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 trastuzumab [Herceptin] - 2 trastuzumab [Herceptin] -
- Primary Outcome Measures
Name Time Method Area under plasma concentration curve of trastuzumab 21 days Maximum observed plasma concentration of trastuzumab 21 days
- Secondary Outcome Measures
Name Time Method Plasma concentration of trastuzumab Day 21 Safety: Incidence of adverse events 21 weeks